Ebglyss (lebrikizumab) / Roche, Almirall, Eli Lilly - LARVOL DELTA

Efficacy and safety of lebrikizumab is maintained up to 3 years in patients with moderate-to-severe atopic dermatitis: ADvocate 1 and ADvocate 2 to ADjoin long-term extension trial (EADV 2024) - No abstract available

Clinical • Late-breaking abstract • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Skin T cells in Atopic Dermatitis lack a profile indicative of IL-4 stimulation (ESDR 2024) - "In addition, the clinical data from lebrikizumab, which selectively blocks IL-13 (not IL-4) confirms a dominant role of IL-13 in AD...In conclusion, our analysis showed no evidence for STAT6 signalling in AD skin T-cells, implying no local stimulation by IL-4. This finding further highlights the dominant role of IL-13, and not IL-4, in AD."

Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Psoriasis • IL13 • IL4 • IL4R • STAT6

Clinical measures of improvement in atopic dermatitis are correlated with reductions in relevant biomarkers in patients treated with lebrikizumab (ESDR 2024) - P3 | "Improvement in IGA was also correlated with a reduction in IgE (correlation coefficient >0.3, p<0.05). Clinical measures of improvement in the signs and symptoms of AD are correlated with reductions in AD biomarkers in patients treated with LEB."

Biomarker • Clinical • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Pruritus • CCL2 • CCL22 • CXCL10 • IL13 • IL4 • IL5 • POSTN

Antibodies to watch in 2024. (PubMed, MAbs) - "In this installment, we discuss key details for 16 antibody therapeutics granted a first approval in 2023, as of November 17 (lecanemab (Leqembi), rozanolixizumab (RYSTIGGO), pozelimab (VEOPOZ), mirikizumab (Omvoh), talquetamab (Talvey), elranatamab (Elrexfio), epcoritamab (EPKINLY), glofitamab (COLUMVI), retifanlimab (Zynyz), concizumab (Alhemo), lebrikizumab (EBGLYSS), tafolecimab (SINTBILO), narlumosbart (Jinlitai), zuberitamab (Enrexib), adebrelimab (Arelili), and divozilimab (Ivlizi))...These nearly 50 product candidates include numerous innovative bispecific antibodies, such as odronextamab, ivonescimab, linvoseltamab, zenocutuzumab, and erfonrilimab, and antibody-drug conjugates, such as trastuzumab botidotin, patritumab deruxtecan, datopotamab deruxtecan, and MRG002, as well as a mixture of two immunocytokines (bifikafusp alfa and onfekafusp alfa)...Our analyses indicate that these molecules have approval success rates in the range of 14-32%, with higher rates..."

Journal • Infectious Disease • Novel Coronavirus Disease • Oncology • Respiratory Diseases

TSLP AND IL-13 Dual Blockade By Lunsekimig Provides Broader Benefits On Type-2 Inflammation (ERS 2024) - "Indeed, lunsekimig was more potent in inhibiting TARC and eotaxin-3 production than targeting TSLP (tezepelumab) or IL-13 (lebrikizumab) alone in an allergen-stimulated triculture assay. Lunsekimig had significantly lowered plasma human IL­13 and TSLP levels, and inflammation in the PBMC-engrafted immunodeficient mice. Conclusion These results support the hypothesis that a dual-targeting approach to TSLP and IL-13 inhibition may result in synergistic function and support the use of lunsekimig in human asthma clinical trials."

Asthma • Inflammation • Respiratory Diseases • IL13 • TSLP

FDA Approves Lilly’s EBGLYSS (lebrikizumab-lbkz) for Adults and Children 12 Years and Older with Moderate-to-Severe Atopic Dermatitis (PRNewswire) - "Eli Lilly and Company...announced today the U.S. Food and Drug Administration (FDA) approved EBGLYSS (lebrikizumab-lbkz), a targeted IL-13 inhibitor, for the treatment of adults and children 12 years of age and older who weigh at least 88 pounds (40 kg) with moderate-to-severe atopic dermatitis (eczema) that is not well controlled despite treatment with topical prescription therapies....The recommended initial starting dose of EBGLYSS is 500 mg (two 250 mg injections) at Week 0 and Week 2, followed by 250 mg every two weeks until Week 16 or later when adequate clinical response is achieved; after this, maintenance dosing is a single monthly injection (250 mg every four weeks)....The approval was based on results from the ADvocate 1, ADvocate 2, and ADhere studies...EBGLYSS will be available in the United States in the coming weeks....Additional markets expected later this year."

Approval • FDA approval • Launch US • Atopic Dermatitis

Improvement Across Dimensions of Disease with Lebrikizumab Use in Atopic Dermatitis: Two Phase 3, Randomized, Double-Blind, Placebo-Controlled Monotherapy Trials (ADvocate1 and ADvocate2). (PubMed, Adv Ther) - P3 | "Lebrikizumab monotherapy resulted in significant and fast improvements in multiple dimensions of disease (clinical signs, symptoms, and quality of life) over 16 weeks in patients with moderate-to-severe atopic dermatitis."

Clinical • Journal • Monotherapy • P3 data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation • Pruritus • IL13

Lebrikizumab Combined with Topical Corticosteroids Improves Patient-reported Outcomes in Japanese Patients with Moderate-to-severe Atopic Dermatitis. (PubMed, Acta Derm Venereol) - "All PRO endpoints for the study were met; patients in the lebrikizumab in combination with topical corticosteroids groups demonstrated statistically significant and clinically meaningful improvements compared with placebo in combination with topical corticosteroids in Skin Pain NRS, DLQI, POEM, WPAI-AD, and SCORAD scales. Lebrikizumab combined with topical corticosteroids compared with placebo+topical corticosteroids improved patient-reported outcomes in Japanese patients with moderate-to-severe atopic dermatitis."

Clinical • Journal • Patient reported outcomes • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Pain

Biologic and Small Molecule Therapy in Atopic Dermatitis. (PubMed, Biomedicines) - "Current therapies include emollients, corticosteroids, cyclosporine A, calcineurin inhibitors, phototherapy, and methotrexate. Biologics described include dupilumab, tralokinumab, lebrikizumab, nemolizumab, and rocatinlimab. Small molecules inhibitors include Janus kinase inhibitors, phosphodiesterase 4 inhibitors, transient receptor potential vanilloid subfamily V member 1 antagonist, and aryl hydrocarbon receptor antagonist."

Journal • Review • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation

An expert consensus on managing dupilumab-related ocular surface disorders in people with atopic dermatitis 2024. (PubMed, Br J Dermatol) - "Although dupilumab is a highly effective agent for treating AD, the risk of ocular adverse effects should not inhibit clinicians or patients from using it, but clinicians should be aware of them. If a patient develops DROSD, there are clear pathways to assess severity and offer initial management; where ineffective, dermatologists should assess the urgency and seek advice from or initiate referral to ophthalmology. While the evidence reviewed for these guidelines reflects the extensive literature on dupilumab, we believe our advice has relevance for ocular surface disorders in atopic dermatitis (AD) patients treated with tralokinumab and lebrikizumab."

Journal • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Infectious Disease • Ocular Inflammation • Ophthalmology • Pediatrics • Transplantation

Maintenance of Lebrikizumab Efficacy in Patients with Moderate-to-Severe Atopic Dermatitis and Atopic Comorbidities (ACAAI 2024) - No abstract available

Clinical • Late-breaking abstract • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

ADorable-2: A Study to Assess the Long-Term Safety and Efficacy of Lebrikizumab (LY3650150) in Participants 6 Months to <18 Years of Age With Moderate-to-Severe Atopic Dermatitis (clinicaltrials.gov) - P3 | N=250 | Enrolling by invitation | Sponsor: Eli Lilly and Company | Recruiting ➔ Enrolling by invitation

Enrollment status • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Dupilumab demonstrates higher likelihood of maintaining efficacy outcomes compared with lebrikizumab in monotherapy at Week 52: results from a placebo-adjusted indirect comparison analysis (EADV 2024) - No abstract available

Clinical • Monotherapy • Atopic Dermatitis • Dermatitis • Dermatology • Dermatopathology • Immunology

Absolute response of lebrikizumab at Week 52 in patients with moderate-to-severe atopic dermatitis who did not achieve protocol-defined response after initial 16 weeks of treatment (EADV 2024) - No abstract available

Clinical • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Raising the bar of efficacy in atopic dermatitis: lebrikizumab maintains depth of response over 2 years (EADV 2024) - No abstract available

Clinical • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Absolute EASI response achieved with lebrikizumab over 52 weeks in patients with moderate-to-severe atopic dermatitis (EADV 2024) - No abstract available

Clinical • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Number needed to treat with lebrikizumab monotherapy at Week 16 in patients with moderate-to-severe atopic dermatitis (EADV 2024) - No abstract available

Clinical • Monotherapy • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Absolute EASI response achieved by lebrikizumab over 16 weeks in patients with moderate-to-severe atopic dermatitis (EADV 2024) - No abstract available

Clinical • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Lebrikizumab improves signs and symptoms of moderate-to-severe atopic dermatitis in patients inadequately controlled or ineligible for cyclosporine: week 52 results of a phase 3 clinical study (ADvantage) (EADV 2024) - No abstract available

Clinical • P3 data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Improvement across disease dimensions with lebrikizumab in combination with topical corticosteroids in atopic dermatitis refractory or ineligible to cyclosporine: results from the ADvantage study (EADV 2024) - No abstract available

Combination therapy • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Absolute itch and quality of life response with lebrikizumab through 52 weeks (EADV 2024) - No abstract available

HEOR • Atopic Dermatitis • Dermatitis • Dermatology • Dermatopathology • Immunology

Lebrikizumab monotherapy maintained improvement of itch and sleep-loss due to itch after two years in patients with moderate-to-severe Atopic dermatitis (EADV 2024) - No abstract available

Clinical • Monotherapy • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Efficacy of lebrikizumab in adults and adolescents with moderate-to-severe atopic dermatitis by age of onset: analysis of two phase 3 clinical trials (EADV 2024) - No abstract available

Clinical • P3 data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Lebrikizumab provides stable skin response with no or minimal fluctuations for up to two years in patients with Atopic dermatitis (EADV 2024) - No abstract available

Clinical • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Dupilumab demonstrates higher likelihood of achieving improvements in signs, symptoms, and quality of life vs lebrikizumab: results from a placebo-adjusted indirect comparison analysis (EADV 2024) - No abstract available

Clinical • HEOR • Atopic Dermatitis • Dermatitis • Dermatology • Dermatopathology • Immunology